Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 17,874 FDA drug recalls.

DateProductReasonClassFirm
Apr 1, 2026 fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg ... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1... cGMP deviations. Class II Wells Pharma of Houston LLC
Apr 1, 2026 Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Sc... Failed Stability Specifications Class II Island Kinetics, Inc. d.b.a. CoValence Laborato...
Apr 1, 2026 EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MED... Lack of Assurance of Sterility Class II International Medication Systems Ltd.
Mar 31, 2026 Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmace... Subpotent drug Class III Avantor Performance Materials LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufac... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufa... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 27, 2026 Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufac... cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin im... Class II Appco Pharma LLC
Mar 26, 2026 Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, ... Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no... Class II Hetero Labs Limited (Unit V)
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceutica... Failed Viscosity Specifications: Out of Specification results, above the specification limit, in... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2026 Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polye... Lack of Assurance of Sterility Class II Preferred Pharmaceuticals, Inc.
Mar 24, 2026 Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x ... Failed Dissolution Specifications Class II The Harvard Drug Group LLC
Mar 24, 2026 GE Healthcare Omnipaque (iohexol) Injection, 300 mg/mL (64.7%), Rx Only, Dist... Presence of particulate matter Class II GE Healthcare Ireland Limited
Mar 24, 2026 GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Dist... Presence of particulate matter Class II GE Healthcare Ireland Limited
Mar 20, 2026 Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by... CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit. Class II Leading Pharma, LLC
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, C... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Me... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, ... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Va... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Men... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Pectin Oral Demulcent, Throat Soothing Drops, Creamy Straw... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, S... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Ho... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Su... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flav... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anest... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar F... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey L... This recall is being initiated following FDA's recommendation based on certain observations noted... Class II Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Mar 20, 2026 Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, F... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, ... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP,... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection US... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 20, 2026 Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP... Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Class II Fagron Compounding Services
Mar 19, 2026 Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Syste... CGMP Deviations: use of an unapproved raw material Class II Teva Pharmaceuticals USA, Inc
Mar 19, 2026 traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manu... Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was f... Class II Amneal Pharmaceuticals, LLC
Mar 18, 2026 Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz n... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Mar 18, 2026 Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per j... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Mar 18, 2026 Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo... Subpotent Drug Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Mar 18, 2026 Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further... Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actua... Class I Amneal Pharmaceuticals, LLC
Mar 17, 2026 Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL S... Labelling: Illegible label Class II Nephron SC, LLC
Mar 17, 2026 Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx ... Failed Dissolution Specifications Class II Viatris, Inc.
Mar 17, 2026 CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-V... Lack of Assurance of Sterility Class II Chiesi USA, Inc.

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.